Comparison between the STENTYS self-apposing bare metal and paclitaxel-eluting coronary stents for the treatment of saphenous vein grafts (ADEPT trial)

Aims To describe the safety and performance of STENTYS self-expandable bare metal stents (BMS) versus paclitaxel-eluting stents (PES) in saphenous vein grafts (SVGs). Methods and Results A randomised controlled trial was performed in four hospitals in three European countries between December 2011 and December 2013. Patients with de novo lesions (>50% stenosis) in an SVG with a diameter between 2.5–6 mm were included. Primary endpoint was late lumen loss at 6 months. Secondary endpoints included procedural success and the occurrence of major adverse cardiac events (MACE) at 12 months. A total of 57 patients were randomised to STENTYS self-apposing BMS (n = 27) or PES (n = 30). Procedural success was obtained in 89.5%. No significant differences in late lumen loss were found between BMS and PES at 6 months (0.53 mm vs 0.47; p = 0.86). MACE rates at 12 months were comparable in both groups (BMS 22.2% vs. PES 26.7%; p = 0.70). Conclusions Treatment of SVGs with STENTYS self-expandable stents is safe and effective. No significant differences were found in late lumen loss and MACE between BMS and PES

OCT assessment of the long-term vascular healing response 5 years after everolimus-eluting bioresorbable vascular scaffold

AbstractBackgroundAlthough recent observations suggest a favorable initial healing process of the everolimus-eluting bioresorbable vascular scaffold (BVS), little is known regarding long-term healing response.ObjectivesThis study assessed the in vivo vascular healing response using optical coherence tomography (OCT) 5 years after elective first-in-man BVS implantation.MethodsOf the 14 living patients enrolled in the Thoraxcenter Rotterdam cohort of the ABSORB A study, 8 patients underwent invasive follow-up, including OCT, 5 years after implantation. Advanced OCT image analysis included luminal morphometry, assessment of the adluminal signal-rich layer separating the lumen from other plaque components, visual and quantitative tissue characterization, and assessment of side-branch ostia “jailed” at baseline.ResultsIn all patients, BVS struts were integrated in the vessel and were not discernible. Both minimum and mean luminal area increased from 2 to 5 years, whereas lumen eccentricity decreased over time. In most patients, plaques were covered by a signal-rich, low-attenuating layer. Minimum cap thickness over necrotic core was 155 ± 90 μm. One patient showed plaque progression and discontinuity of this layer. Side-branch ostia were preserved with tissue bridge thinning that had developed in the place of side-branch struts, creating a neo-carina.ConclusionsAt long-term BVS follow-up, we observed a favorable tissue response, with late luminal enlargement, side-branch patency, and development of a signal-rich, low-attenuating tissue layer that covered thrombogenic plaque components. The small size of the study and the observation of a different tissue response in 1 patient warrant judicious interpretation of our results and confirmation in larger studies

Current status of clinically available bioresorbable scaffolds in percutaneous coronary interventions

Drug-eluting stents (DES) are widely used as first choice devices in percutaneous coronary interventions. However, certain concerns are associated with the use of DES, i.e. delayed arterial healing with a subsequent risk of neo-atherosclerosis, late stent thrombosis and hypersensitivity reactions to the DES polymer. Bioresorbable vascular scaffolds are the next step in percutaneous coronary interventions introducing the concept of supporting the natural healing process following initial intervention without leaving any foreign body materials resulting in late adverse events. The first-generation devices have shown encouraging results in multiple studies of selected patients up to the point of full bioresorption, supporting the introduction in regular patient care. During its introduction in daily clinical practice outside the previously selected patient groups, a careful approach should be followed in which outcome is continuously monitored

Short- and long-term outcomes in octogenarians undergoing percutaneous coronary intervention with stenting

Aims: To investigate the incidence of cardiac events in octogenarians who underwent percutaneous coronary intervention (PCI) with stenting, as well as to evaluate the efficacy and safety of drug-eluting stents (DES) in this population. Methods and results: The study included 6,129 consecutive patients who underwent PCI with stenting from 2000 to 2005 in our centre, of whom 291 (4.7%) were octogenarians. After adjusting for confounders, age ≥80 years appeared a significant predictor of high mortality at 30 days (adjusted hazard ratio [aHR]1.92, 95% CI1.23-3.01), and four years (aHR 2.25, 95% CI1.77-2.85). No differences were seen with respect to incident myocardial infarction (MI), but target lesion (63.2 vs. 32.6 per1,000 person-years at one year and 27.9 vs.16.6 per1,000 person-years at four years) and vessel (83.1 vs. 52.9 per1,000 person-years at one year and 37.7 vs. 25.0 per1,000 person-years at four years) revascularisation rates were lower in octogenarians. When com

Magnetic navigation system assisted stenting of coronary bifurcation lesions

Aims: Magnetic guidewire assisted percutaneous coronary interventions (MPCI) could have certain advantages in coronary bifurcation lesions. We aimed to report the angiographic characteristics of the bifurcation lesions, as well as the procedural and clinical outcomes of the MPCI patients. Methods and results: The lesion characteristics and the treatment effect were assessed by performing diagnostic and quantitative coronary angiography with dedicated bifurcation software. A total of 76 patients (age 65 years, 78% male) were assigned to undergo MPCI, in which two-thirds of the lesions were located in LAD/D1. Fifty-seven out of 78 lesions (73%) had a diseased side branch and complex stenting techniques were used in the majority of the lesions (64%). All 59/78 (76%) fenestration attempts were successfully performed and only 13 dedicated bifurcation stents were implanted. The average acute gain in minimal luminal diameter was 1.08±0.81mm, 0.80±0.70 mm and 0.59±0.5

Impact of multiple balloon inflations during primary percutaneous coronary intervention on infarct size and long-term clinical outcomes in ST-segment elevation myocardial infarction: Real-world postconditioning

Interrupting myocardial reperfusion with intermittent episodes of ischemia (i.e., postconditioning) during primary percutaneous coronary intervention (PPCI) has been suggested to protect myocardium in ST-segment elevation myocardial infarction (STEMI). Nevertheless, trials provide inconsistent results and any advantage in long-term outcomes remains elusive. Using a retrospective study design, we evaluated the impact of balloon inflations during PPCI on enzymatic infarct size (IS) and long-term outcomes. We included 634 first-time STEMI patients undergoing PPCI with an occluded infarct-related artery and adequate reperfusion thereafter and divided these into: patients receiving 1-3 inflations in the infarct-related artery [considered minimum for patency/stent placement (controls); n = 398] versus ≥4 [average cycles in clinical protocols (postconditioning analogue); n = 236]. IS, assessed by peak creatine kinase, was lower in the postconditioning analogue group compared with controls [median (interquartile range) 1,287 (770-2,498) vs. 1,626 (811-3,057) UI/L; p = 0.02], corresponding to a 21 % IS reduction. This effect may be more pronounced in women, patients without diabetes/hypercholesterolemia, patients presenting within 3-6 h or with first balloon re-occlusion ≤1 min. No differences were observed in 4-year mortality or MACCE between groups. Four or more inflations during PPCI reduced enzymatic IS in STEMI patients under well-defined conditions, but did not translate into improved long-term outcomes in the present study. Large-scale randomized trials following strict postconditioning protocols are needed to clarify this effect